In early February 2015, the New York State attorney general’s office launched an investigation into store-brand supplements by four national retailers: GNC, Target, Walgreens, and Wal-Mart (see recent news reports here and here). Not surprisingly, class action lawsuits have been filed alleging these retailers are selling misbranded or adulterated products.
In early February 2015, the New York State attorney general’s office launched an investigation into store-brand supplements by four national retailers: GNC, Target, Walgreens, and Wal-Mart (see recent news reports here and here). Not surprisingly, class action lawsuits have been filed alleging these retailers are selling misbranded or adulterated products. I provided some preliminary thoughts on this breaking news in an interview that I did for A2L Consulting on February 6th. I thought it might be helpful to expand on some of this thinking in a blog post.
So, exactly what do these class action lawsuits allege and how can natural product manufacturers ensure that they don’t get sued or that they prevail in this type of litigation?
ISS has provided scientific support to dietary supplement manufacturers in many types of legal actions, including actions by government agencies and departments (e.g., Federal Trade Commission (FTC), Attorneys Generals, and District Attorneys) as well as private consumer fraud actions. In this work we have seen the following four broad types of claims being made by our clients’ adversaries.
1. Content Claims
The most basic consumer fraud allegation that can be made about a supplement manufacturer’s product is that it doesn’t contain the ingredient(s) (or the amounts of the ingredients) as stated on the product label. The content of a dietary supplement is explicitly regulated by The Nutrition Labeling and Education Act of 1990 (NLEA). Scientific studies have evaluated the accuracy of supplement ingredient content claims for well over ten years and the assertion that these products don’t contain labeled amounts of their ingredients is certainly not new.
It is incumbent upon a manufacturer to adhere to good manufacturing practices (GMPs). If these practices are followed rigorously, it is unlikely that there could be vast discrepancies between labeled content and how much of a given ingredient is actually found in the product.
2. Misleading Advertising Claims
Another common allegation made against dietary supplement manufacturers in consumer fraud actions is that the benefits of the product are not supported by competent and reliable scientific evidence. Supplement manufacturers are allowed to make structure function claims about their product if these claims are supported by appropriate scientific studies. A structure/function claim is one that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.
Nevertheless, advertising claims pertaining to the structure and function of the body must be supported by competent and reliable scientific evidence. We and others have written about the importance of rigorous scientific substantiation (i.e., competent and reliable scientific evidence) for dietary supplement structure/function advertising claims. This support is then used effectively in litigation challenging the validity of effectiveness advertising claims.
Interestingly (and not surprisingly), recent data support the view that products that have good scientific support for efficacy tend to do better in the marketplace.
3. Product Adulteration
Another legal claim related to the recent New York attorney general investigation is that some supplement products contain adulterants and contaminants. While these claims might lead to allegations of personal injury (see below), they might also simply lead to consumer fraud claims (i.e., a consumer claiming that he or she didn’t purchase a fish oil product that contained other adulterants). It is likely that sourcing of dietary supplement ingredients from overseas could explain the cause of these adulterants. As stated above, if a manufacturer is rigorously following GMP standards, any contaminants or adulterants should be detected.
4. Personal Injury
Finally, legal claims involving dietary supplement products could take the form of personal injury product liability. Claims could involve allegations that the ingredients are present in quantities that are known to cause adverse health effects. For example, certain dietary ingredients are well known to have toxicity at high enough doses (e.g., liver toxicity from exposure to kava kava).
Toxicity from dietary ingredients in supplements has been written about in the scientific literature as well as in the more mainstream popular press. Of course, dietary supplement manufacturers should give special consideration to their products when used in special populations (e.g., the elderly, infants, children, genetically-defined subpopulations, women, etc.) for potentially idiosyncratic reactions.
Are you ready to defend your product or your client’s product? As described in this post, dietary supplements can come under scrutiny from a variety of angles (e.g. FDA, FTC, AGs, DAs, consumers). ISS has provided scientific support to dietary supplement manufacturers and their attorneys in many types of legal actions. Contact us for more information on how we can help you with your case.
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